What is NDC 63323-820?

63323-820 is the product NDC for Smoflipid, Soybean oil 6 g/100mL + 3 more ingredients injection, emulsion, listed with the FDA by Fresenius Kabi USA, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Soybean oil, Medium-chain triglycerides, Olive oil, Fish oil.

Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Smoflipid?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Smoflipid NDC 63323-820 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-820Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0820Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
63323-820-00	63323082000	10 BAG in 1 CASE (63323-820-00) / 100 mL in 1 BAG (63323-820-01)Marketed from Jul 13, 2016
63323-820-10	63323082010	6 BAG in 1 CASE (63323-820-10) / 1000 mL in 1 BAG (63323-820-05)Marketed from May 27, 2019
63323-820-12	63323082012	20 BAG in 1 CASE (63323-820-12) / 100 mL in 1 BAG (63323-820-02)Marketed from Jul 13, 2016
63323-820-50	63323082050	12 BAG in 1 CASE (63323-820-50) / 500 mL in 1 BAG (63323-820-03)Marketed from Jul 13, 2016
63323-820-74	63323082074	10 BAG in 1 CASE (63323-820-74) / 250 mL in 1 BAG (63323-820-04)Marketed from Jul 13, 2016

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Smoflipid
Generic name (nonproprietary): smoflipid
Active ingredients: Soybean oil — 6 g/100mLMedium-chain triglycerides — 6 g/100mLOlive oil — 5 g/100mLFish oil — 3 g/100mL
Dosage form: Injection, Emulsion
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 207648
Marketing start: Jul 13, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Lipids (Chemical structure)Lipids (Chemical structure)
Identifiers: Product ID 63323-820_9fd35691-76ee-486c-bd65-b47d3df2fef4SPL ID 9fd35691-76ee-486c-bd65-b47d3df2fef4SPL set ID e0e9d917-ff6f-488e-a6a8-0ad59dd17d80UNII 241ATL177A, C9H2L21V7U, 6UYK2W1W1E, XGF7L72M0F
Pharmacologic class: Lipid Emulsion

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N463323082000 followed by a unit qualifier and the quantity

Package 63323-0820-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Aug 15, 2025.

Indications (excerpt from the label)

SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-820

What is NDC 63323-820?: 63323-820 is the product NDC for Smoflipid, Soybean oil 6 g/100mL + 3 more ingredients injection, emulsion, listed with the FDA by Fresenius Kabi USA, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Smoflipid.
What is the active ingredient?: Soybean oil, Medium-chain triglycerides, Olive oil, Fish oil.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Smoflipid?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.